[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053616":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":53,"id":60,"slug":20,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-guided Virtual Reality (VR) Session","EXPERIMENTAL","The intervention is a single-day 45-minute VR intervention which is subdivided into 3 smaller sessions:\n\nSession 1: A 15-minute AI check-in to ask questions about biopsychosocial health Session 2: A 20-minute Pain Coping Skills Training (PCST) session offering psychoeducation on managing chronic pain Session 3: A 10-minute stress reduction exercise.",[13],"Device: VR Headset Device - Meta Quest 3",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","VR Headset Device - Meta Quest 3","The VR sessions will be conducted using hardware and software developed by AugMend Health Company. The AI-guided sessions will be administered using the commercially available Meta Quest 3 headset, which delivers high-resolution VR images and spatial audio through a standalone, wireless system.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Moorice A Caparo, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Ugur Yener, MD","CONTACT","(718) 405-8360","uyener@montefiore.org",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Hatice B Ciftci, MD","hciftci@montefiore.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Montefiore Multidisciplinary Pain Medicine Program (MMPP) at Montefiore Einstein Hutchinson Campus","RECRUITING","The Bronx","New York","10467","United States",{"type":43,"coordinates":44},"Point",[45,46],-73.86641,40.84985,{"lat":46,"lon":45},[49],{"name":27,"role":28,"phone":50,"phoneExt":20,"email":30},"718-405-8360",{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54,57],{"name":55,"class":56},"National Institute on Drug Abuse (NIDA)","NIH",{"name":58,"class":59},"AugMend Health","UNKNOWN","100053616",false,"NCT07124598","Virtual Intelligence for Transformative Lifestyle Solutions in Pain","VITALS-Pain","Inclusion Criteria:\n\n* Patients with opioid misuse or International Classification of Diseases 10th revision (ICD-10) diagnosis of opioid use disorder\n* Patients with Chronic pain of at least moderate intensity (\\>4 Pain Intensity Score) with no pain medication changes in 14 days\n* Ability to understand written\u002Fspoken instruction and provide informed consent in English\n* Ability and willingness to participate in all components of the study\n\nExclusion Criteria:\n\n* History of severe motion sickness, cybersickness, or conditions that could make participation in VR hazardous or cause adverse effects\n* Conditions that could prevent proper use of VR headset (such as vision problems that cannot be corrected by contact lenses or glasses that fit in VR, Significant hearing impairments that cannot be corrected by a hearing device)\n* History of seizures or seizure disorder\n* Acute exacerbation of psychiatric conditions such as self-injurious behaviors or suicidal risk that preclude the ability to participate in the study","ALL","18 Years",{"count":69,"type":70},15,"ESTIMATED","INTERVENTIONAL",[73],"NA","This pilot study aims to evaluate the feasibility and acceptability of a VR-based chronic pain management intervention with a virtual AI coach for patients with Opioid misuse and opioid use disorder (OM\u002FOUD). The intervention is a single-day 45-minute VR intervention which is subdivided into three smaller sessions:\n\nSession 1: A 15-minute AI check-in to ask questions about biopsychosocial health, Session 2: A 20-minute Pain Coping Skills Training (PCST) session offering psychoeducation on managing chronic pain Session 3: A 10-minute stress reduction exercise.\n\nThe VR sessions will be conducted using hardware (VR Headset Device - Meta Quest 3) and software developed by AugMend Health Company.\n\nThe study will be conducted in a clinical setting at the Montefiore Multidisciplinary Pain Medicine Program (MMPP), a Pain Medicine outpatient specialty practice within a major urban medical center. MMPP providers see thousands of patients every month, some of which have concurrent opioid misuse or OM\u002FOUD.",[76],"Chronic Pain",[78,79,80,81],"Virtual Reality (VR)-based Chronic Pain Management","Opioid Management","Opioid Use Disorder","Artificial Intelligence (AI)","2026-07-10",{"date":84,"type":85},"2026-07-13","ACTUAL",{"date":82,"type":85},{"date":88,"type":70},"2026-12",{"name":5,"class":6},1]